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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00557440 |
This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of QMF Twisthaler compared to placebo and using fluticasone propionate/salmeterol as an active control.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Fluticasone propionate/salmeterol Drug: Indacaterol maleate / mometasone furoate Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF Twisthaler in Adult Patients With Persistent Asthma |
Enrollment: | 37 |
Study Start Date: | November 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Indacaterol maleate / mometasone furoate
QMF Twisthaler 500/400 μg o.d.
|
2: Placebo Comparator |
Drug: placebo
Placebo b.i.d.
|
3: Active Comparator |
Drug: Fluticasone propionate/salmeterol
Fluticasone/salmeterol 250/50 μg b.i.d.
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with persistent asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Belgium | |
Novartis Investigator site | |
Ghent, Belgium | |
Novartis Investigator Site | |
Aalst, Belgium | |
Germany | |
Novartis Investigator Site | |
Landsberg, Germany | |
Novartis Investigator Site | |
Rostock, Germany | |
Novartis Investigator Site | |
Hannover, Germany | |
Novartis Investigator Site | |
berlin, Germany |
Study Chair: | Novartis Pharma | Novartis Pharma |
Responsible Party: | novartis ( external affairs ) |
Study ID Numbers: | CQMF149A2202 |
Study First Received: | November 12, 2007 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00557440 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices |
Asthma QMF Indacaterol Mometasone |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents |
Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents |
Salmeterol Immune System Diseases Adrenergic beta-Agonists Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |